- Sumitomo Pharma (Trenton, NJ)
- …a dynamic, highly motivated, and experienced individual for the position of ** Associate Medical Director.** The Associate Medical Director will provide hands-on ... + Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a… more
- Sumitomo Pharma (Trenton, NJ)
- …a dynamic, highly motivated, and experienced individual for the position of ** Associate Manager, Compliance, Training & Strategic Alliance (CTSA), PVRM** . The ... Associate Manager, Compliance, Training & Strategic Alliance (CTSA), PVRM...(CTSA), PVRM is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will… more
- United Therapeutics (Trenton, NJ)
- …are passionate about PV and enjoy being part of a collaborative team. The Associate Global PV Case Management Director plays a key role in management and oversight ... role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation,… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …candidates with a less traditional background. **Job Description** We are seeking an Associate for our North America Medical Affairs team. This is a critical role ... within our Pharmacovigilance and Medical Affairs team. The incumbent will be...NJ (Hybrid) and will report directly to the Head Pharmacovigilance and Medical Affairs - North America **Responsibilities:** *… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. Associate Director, Global Patient Safety Medical Science reports to Head of GPS Medical ... + Assists Head of GPS Medical Science for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary:** The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and other vendors to ensure high quality of laboratory data… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary:** The Associate Director, Data Management Processes, Training and Inspection Readiness, is ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and other vendors to ensure high quality of deliverables to… more
- Haleon (Warren, NJ)
- …In line with a risk-proportionate framework for product vigilance, the ** Associate Director, Consumer Safety Science** is accountable for developing the safety ... + 5 years+ experience in similar role with extensive knowledge in pharmacovigilance . + In-depth knowledge in causality assessment, evaluation of safety signals and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …research through post-marketing + Strong experience in Good Clinical and Good Pharmacovigilance Practices and knowledge of evolving regulations, such as ICH E6 R3 ... + Proven experience advising business functions in the biopharma industry on quality and compliance requirements and continuous improvement + Experience working across a broad spectrum of quality and/or compliance activities, including authoring SOPs, leading… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies with all… more